1. Field
Embodiments of the present invention relate tools for quantitatively measuring parameters such as force, shear, hardness, pressure, etc., generated during manual diagnosis, treatment, and evaluation of patients.
2. Discussion of Related Art
Frequently, patient diagnosis and treatment involves a clinician placing his or her hands upon the patient. Manual healthcare providers are increasingly adopting leading edge technologies to improve these diagnoses and treatments. However, in physical therapy, chiropractics, and general medicine, the classical standard of manual care and diagnosis remains the qualitative biologic sensors within the clinician's hands.
Manual diagnosis and therapy encompasses numerous disciplines but is most prevalently practiced by physical therapists, chiropractors, orthopedists, and doctors of osteopathy. Together, these sectors of physical medicine may treat over 70% of the U.S. population for ongoing care, and representing an industry value of greater than $130 billion. Specifically, the growing aging population is increasing demand for chiropractic care, and the U.S. annually spends more than $42 billion in treating lower back pain alone. These expenses and high incidence of treatment highlight physical medicine's importance in the health of our nation.
Manual diagnosis and therapy classically involves the physical application of loads to the body to produce joint displacements, altered local stress, and/or relief of pain and discomfort. This physical application of loads to the body is not currently widely measured in clinical practice. Waddington et al. in “Initial development of a device for controlling manually applied forces,” Manual Therapy 2007: 12(2):133-8, noted that “ . . . substantial variability has been shown when therapists attempt to replicate an applied force.” This variability can significantly alter the effectiveness of the clinician to achieve their desired clinical outcome.
Specific examples in manual diagnosis and therapy that would benefit from objective measures of the applied loads include: provocative tests to evaluate painful joints, evaluation of patient improvement, and delivery of safe forces to the patient. From visit to visit, a record of the forces applied to a specific patient would improve patient care and the ability of the clinician to evaluate patient progress. In the assessment of thoracic spine manipulations, intra-clinician variability was measured to be as high as 42% for chiropractors attempting to reproduce a particular outcome. Pain-provocation tests on patients have likewise been found to vary considerably between tests and clinicians. Levin et al. reported that “The findings indicate the advantage of registering pressure force as a complement for standardized methods for pain-provoking tests and when learning provocation tests, since individual variability was considerable.”
Manual palpation methods for diagnosis and treatment have long suffered from objectivity, inter-examiner variability, and intra-examiner variability. Until recently, very few scientific studies have quantified manipulation procedures to associate biomechanical manipulation with relief of symptoms. The following review describes both the state of the art in measurement techniques and the results and benefits of manipulation force measurement.
Quantifying manual force application has been accomplished theoretically, through inverse dynamics, and via direct measurement. Measurement of the forces clinicians apply to their patients has been accomplished using instrumented tools, gloves, and tables. Together, these measurement systems have improved the knowledge base for physical medicine and individual patient care.
At some point in their lives, most people may receive physical treatment for musculoskeletal ailments, such as muscle strains, ligament sprains, joint replacements, and arthritis. More than seventy percent of the U.S. population may seek clinical care that is physical or biomechanical in nature. The clinical care sought may include physical therapy, orthopedic surgery, or chiropractic care, for example. Treatments in these specialties rely on the forces that the clinician applies with their hands. Unfortunately, hospitals and clinics currently lack a tool for the measurement of these forces, leaving diagnosis and treatment subjective.
In this age of evidence based clinical care, objective measurements of the forces clinicians apply to their patients may lead to wide-spread improvements in care. Current clinical biomechanical assessments and treatments contain variability between clinicians and visits which has been shown to influence outcomes. Previous research has identified the need for a tool to measure forces at the hands in clinical diagnosis and treatment. Unfortunately, no universally applicable off-the-shelf measurement system exists.
As evidence based medicine advances and improves the healthcare industry, it is imperative that manual diagnosis and therapy remain on the leading edge due to their importance to patient health. Quantification of the physical forces that clinicians apply to their patients represents a significant step towards defining and motivating evidence-based outcomes in physical medicine. Although many different traditional sensors have been used to assist the clinician in understanding the forces they are applying to their patients, few of these devices measure the direct forces between the clinician and patient, and none are widely available to clinicians.